The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Ife-15 Pentavalent, Model 3456, Spife Ife-9 Pentavalent Kit, Model 3457, Spift Ife-6 Pentavalent Kit, Model 3458.
| Device ID | K061069 |
| 510k Number | K061069 |
| Device Name: | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Patricia Franks |
| Correspondent | Patricia Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | CFF |
| Subsequent Product Code | DEH |
| Subsequent Product Code | DFH |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-17 |
| Decision Date | 2006-07-06 |
| Summary: | summary |